Clotting Risk Sparks National Blood Thinner Recall

An independent pharmaceutical manufacturer issued an urgent notice regarding its blood thinner that was distributed nationwide.

Par Health is recalling 22 lots of Argatroban Injection due to the detected presence of a foreign object that could potentially cause blood clots in the lungs, according to a U.S. Food and Drug Administration (FDA) public health alert.

The foreign object was identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.

“Administration of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting,” federal officials said.

The recalled lots were distributed nationwide to wholesalers and hospitals between Dec. 30, 2024, and May 5.

As of Oct. 20, there were no reports of adverse events related to the medicine.

The withdrawal applies to 3,600 cartons of 150 mg, 60-count blister packs, 924 cartons of 75 mg, 60-count blister packs, and 936 cartons of 75 mg, 30-count blister packs.

“Failed impurity/degradation specification,” the FDA report states.

Specifically, the FDA said 12-month stability testing revealed levels of Impurity II, Impurity III, and total impurities above acceptable specifications.

https://www.ntd.com/clotting-risk-sparks-national-blood-thinner-recall_1180135.html